Metformin Treatment of Patients with Hand Osteoarthritis

NCT06367283 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 2023-509181-38-00
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

To compare metformin (2 g daily), or maximum tolerated dose, for 16 weeks with placebo as a treatment of hand osteoarthritis symptoms.

Conditions

Hand Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Finger pain

  Change from baseline in Visual Analogue Scale (VAS) finger joint pain of the target hand after 16 weeks of treatment

  Week 16

Secondary Outcomes (8)

• Function

  Week 16

• Thumb base pain

  Week 16

• Hand pain

  Week 16

• Physician tender joint count

  Week 16

• Patient global assessment

  Week 16

Other Outcomes (14)

• Stiffness of both hands

  Week 16

• Composite of pain, function and stiffness

  Week 16

• Physical function

  Week 16

Study Arms (2)

Metformin

EXPERIMENTAL

Drug: Metformin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Metformin DRUG

Metformin will be initiated at 500 mg once daily with breakfast meal. The dose will be increased with 500 mg every week until 2 g/day is reached, distributed as 1000 mg every morning and evening, together with a meal. If the subject cannot tolerate the maximum dose (2 g/day), the maximal tolerated dose will be given. The treatment period including titration is 16 weeks.

Metformin

Placebo DRUG

Participants in the placebo group will receive a placebo tablet identical to the metformin tablet

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Hand OA according to the ACR criteria
• Average finger (2 to 5) pain ≥4 on a 0-10 numeric rating scale (NRS where 10 is worst pain) over the past 30 days
• Metformin naive

You may not qualify if:

• Comorbidities
• History of, or current signs of medical disease that may affect joints, e.g. rheumatoid arthritis, gout, psoriatic arthritis
• Psoriasis
• Known malignancy (except successfully treated squamous or basal cell skin carcinoma)
• Drug or alcohol abuse in the last year
• Existing nerve entrapment syndromes (e.g. carpal tunnel syndrome)
• Known diabetes
• Generalised pain syndromes such as fibromyalgia
• Known peripheral neuropathies
• Known allergies towards the interventions
• Gastric bypass or other malabsorption syndrome
• In case of pharmacological weight loss medication (e.g. glucagon like peptide-1 (GLP-1) analogues) or pharmacological osteoporosis medication, dosage must have been stable for 3 months without any plan of up-titration during the study period
• Any other condition or impairment that, in the opinion of the investigator, makes a potential participant unsuitable for participation or obstructs participation e.g. psychiatric disorders.
• Surgical history
• History of hand surgery in the target hand within 12 months prior to enrolment

Sponsors & Collaborators

• Marius Henriksen: lead

Study Sites (1)

The Parker Institute, Bispebjerg and Frederiksberg hospital

Copenhagen, Frederiksberg, 2000, Denmark

RECRUITING

Related Publications (1)

• Madsen KS, Henriksen M, Dossing A, Poulsen AS, Oscar R, Kragstrup T, Ellegaard K, Knop FK, Boesen M, Hunter DJ, Christensen R, Bliddal H. Metformin treatment for patients with hand osteoarthritis: protocol for the multicentre, randomised, placebo-controlled METRO trial. BMJ Open. 2025 Mar 26;15(3):e093831. doi: 10.1136/bmjopen-2024-093831.

  PMID: 40139705 DERIVED

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Central Study Contacts

Kasper Staberg Madsen

CONTACT

+4538164162; kasper.staberg.madsen@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 16, 2024
• Study Start: June 3, 2024
• Primary Completion: December 1, 2025
• Study Completion: April 1, 2026
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)